New standards to reduce contaminants in prescription drugs

Armen Hareyan's picture
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Prescription medicines in the United States could soon have lower levels of potentially harmful metals, as the organization that sets drug standards develops new limits for impurities like mercury, arsenic, and lead, according to an article scheduled for the December 8 issue of Chemical & Engineering News, ACS' weekly newsmagazine.

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In the article, C&EN Associate Editor Jyllian Kemsley notes that researchers have known for years that potentially toxic metals can wind up in pharmaceutical ingredients through raw materials, catalysts, equipment, and other sources. But the testing method currently prescribed by the U.S. Pharmacopeia (USP), the nonprofit organization that sets standards for the pharmaceutical industry, has not kept pace with that new knowledge.

That method involves a 100-year-old test that is time-consuming, difficult to interpret, and generally not quantitative, according to the article.

USP now is developing new standards and testing methods that will be finished in 2010 and implemented over a span of years. USP will require drug makers to use improved methods and instruments to detect metal contaminants.

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